OPTIMA MPT MODEL 5281E AND MODEL 5282E

OPTIMA MPT MODEL 5281E AND MODEL 5282E is an FDA 510(k)-cleared medical device (K897116) manufactured by Telectronics Pacing Systems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on March 13, 1990. Regulation: 8.